Overview
Glyburide is a second generation sulfonylurea used to treat patients with diabetes mellitus type II. It is typically given to patients who cannot be managed with the standard first line therapy, metformin. Glyburide stimulates insulin secretion through the closure of ATP-sensitive potassium channels on beta cells, raising intracellular potassium and calcium ion concentrations. Glyburide was granted FDA approval on 1 May 1984. A formulation with metformin was granted FDA approval on on 31 July 2000.
Indication
Glyburide is indicated alone or as part of combination product with metformin, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
Associated Conditions
- Gestational Diabetes Mellitus (GDM)
- Glycemic Control
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/10 | Not Applicable | Not yet recruiting | |||
2023/01/18 | Phase 2 | Recruiting | |||
2023/01/18 | Phase 3 | Not yet recruiting | |||
2022/06/22 | Phase 1 | Recruiting | |||
2021/12/08 | Phase 1 | UNKNOWN | Beijing Tiantan Hospital | ||
2021/11/30 | Phase 4 | UNKNOWN | Beijing Tiantan Hospital | ||
2021/07/14 | Not Applicable | Completed | |||
2021/04/26 | Phase 1 | Completed | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2020/01/18 | Not Applicable | Completed | |||
2019/05/17 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc. | 68071-2402 | ORAL | 5 mg in 1 1 | 5/13/2021 | |
| Aurobindo Pharma Limited | 65862-082 | ORAL | 5 mg in 1 1 | 3/16/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-5215 | ORAL | 5 mg in 1 1 | 4/5/2021 | |
| Blenheim Pharmacal, Inc. | 10544-580 | ORAL | 2.5 mg in 1 1 | 2/18/2015 | |
| NuCare Pharmaceuticals,Inc. | 68071-5029 | ORAL | 2.5 mg in 1 1 | 2/19/2021 | |
| Aidarex Pharmaceuticals LLC | 33261-209 | ORAL | 5 mg in 1 1 | 1/4/2014 | |
| Teva Pharmaceuticals USA, Inc. | 0093-8036 | ORAL | 6 mg in 1 1 | 9/12/2023 | |
| Bryant Ranch Prepack | 71335-0069 | ORAL | 2.5 mg in 1 1 | 4/2/2021 | |
| Pharmacia & Upjohn Company LLC | 0009-0352 | ORAL | 3 mg in 1 1 | 12/6/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-2589 | ORAL | 5 mg in 1 1 | 4/25/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/24/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CLAMIDE TABLET 5 mg | SIN07380P | TABLET | 5.00MG | 4/3/1993 | |
| GLYBORAL TABLET 5 mg | SIN11789P | TABLET | 5 mg | 1/26/2002 | |
| T.O.NIL TABLET 5 mg | SIN10998P | TABLET | 5 mg | 6/26/1999 | |
| APO-GLYBURIDE TABLET 5 mg | SIN04842P | TABLET | 5 mg | 6/26/1990 | |
| BENIL TABLET 5 mg | SIN07284P | TABLET | 5 mg | 12/3/1992 | |
| GLIMIDE TABLET 5 mg | SIN04206P | TABLET | 5 mg | 4/17/1990 | |
| GLUCOVANCE TABLET 500 mg/5 mg | SIN12322P | TABLET, FILM COATED | 5 mg | 6/23/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GLUCOVANCE 500/5 metformin hydrochloride 500 mg and glibenclamide 5 mg tablet blister pack | 96729 | Medicine | A | 8/5/2004 | |
| DAONIL 5mg Tablets | 73683 | Medicine | A | 4/27/2000 | |
| GLUCOVANCE 250/1.25 metformin hydrochloride 250 mg and glibenclamide 1.25 mg tablet blister pack | 96725 | Medicine | A | 8/5/2004 | |
| GLUCOVANCE 500/2.5 metformin hydrochloride 500 mg and glibenclamide 2.5 mg tablet blister pack | 96728 | Medicine | A | 8/5/2004 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| RIVA-GLYBURIDE | pharmel inc | 02236543 | Tablet - Oral | 2.5 MG | 6/4/1998 |
| GLYBURIDE | PRO DOC LIMITEE | 01959352 | Tablet - Oral | 2.5 MG | 12/31/1992 |
| NTP-GLYBURIDE | teva canada limited | 02345854 | Tablet - Oral | 2.5 MG | N/A |
| NU-GLYBURIDE TAB 5MG | nu-pharm inc | 02020742 | Tablet - Oral | 5 MG | 12/31/1993 |
| MED GLYBE TAB 5MG | medican pharma incorporated | 02085887 | Tablet - Oral | 5 MG | 12/31/1994 |
| GLYBURIDE TABLETS 2.5MG | prempharm inc | 02230036 | Tablet - Oral | 2.5 MG | 12/23/1996 |
| GLYBURIDE TABLETS 5MG | prempharm inc | 02230037 | Tablet - Oral | 5 MG | 12/23/1996 |
| GLYBURIDE | sanis health inc | 02350467 | Tablet - Oral | 5 MG | 5/12/2010 |
| DIABETA TAB 2.5MG | hoechst canada inc. | 00454753 | Tablet - Oral | 2.5 MG / TAB | 12/31/1978 |
| AVA-GLYBURIDE | avanstra inc | 02363704 | Tablet - Oral | 2.5 MG | 8/11/2011 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| AMGLIDIA 6 mg/ml SUSPENSION ORAL | 1181279003 | SUSPENSIÓN ORAL | Diagnóstico Hospitalario | Not Commercialized | |
| AMGLIDIA 0,6 mg/ml SUSPENSION ORAL | 1181279001 | SUSPENSIÓN ORAL | Diagnóstico Hospitalario | Not Commercialized | |
| GLUCOLON 5 MG COMPRIMIDOS | Laboratorio Generfarma S.L. | 50337 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| DAONIL 5 mg COMPRIMIDOS | Sanofi Aventis S.A. | 48545 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.